Appendix B

Appendix B: United States Vaccines...... B-3

Vaccine Excipient Table...... B-7

Latex in Packaging ...... B-11.

Vaccine-Preventable Disease Terms in Multiple Languages...... B-13.

Resources for Vaccines...... B-15

B

Appendix B-1 Appendix B

B

Appendix B-2 Appendix B Comments Inactivated, Adj. Inactivated, Adj. Recombinant, Inactivated, Adj. Inactivated, Inactivated, Adj. Adj. Inactivated, conjugate) (Meningococcal Inactivated (Tetanus toxoid Inactivated (Tetanus conjugate) Recombinant, Adj. Recombinant, Adj. Recombinant, Inactivated, Adj. Inactivated, Use Adj.: Inactivated, when pertussis is contraindicated toxoid Inactivated (Tetanus conjugate) Live: Approved for military for Approved Live: not approved populations; women pregnant for from filtrate Cell-free Adj. strain, avirulent Recombinant, Adj. Recombinant, Live Attenuated Live Adj. Inactivated,

Approved Ages Approved Pediatric: Pediatric: years; 12 months-18 ≥19 years Adult: Pediatric: years Birth-19 ≥20 years Adult: 12 months-18 years; years; 12 months-18 ≥19 years Adult: 2-71 months Pediatric: 6 weeks- 4 years 6 weeks- ≥18 years ≥50 years 6 weeks-6 years 6 weeks-6 years 6 weeks-6 years 2 months-5 17-50 years 18-65 years Birth-19 years years Birth-19 ≥20 years Adult: 18-64 years years 6 weeks-6 Pediatric: Series Doses in Routine 2 3 3 2 4 2 2 5 5 4 1 3 1 5 3 Route IM IM IM IM IM IM IM IM IM IM IM Oral (2 Tablets) IM Oral (Liquid) Oral IM Manufacturer Merck Merck GlaxoSmithKline Merck GlaxoSmithKline GlaxoSmithKline Dynavax Technologies GlaxoSmithKline GlaxoSmithKline Sanofi Sanofi Teva Pharmaceutical Industries Ltd. Emergent BioSolutions Emergent Emergent BioSolutions Sanofi Abbreviation HepB HepA HepB Hib (PRP-OMP) HepA Hib (PRP-T) HepB RZV DTaP DT Hib (PRP-T) N/A AVA N/A DTaP † Trade Name Trade Recombivax HB® Recombivax Vaqta® Engerix-B™ PedvaxHIB® Havrix™ Hiberix™ Heplisav-B® Shingrix™ Infanrix™ N/A (Generic) ActHIB® Adenovirus 7 Type 4 & Type BioThrax® Vaxchora™ Daptacel®

B Vaccine Hepatitis B Hepatitis Hepatitis A Hepatitis Herpes Zoster Herpes Zoster (Shingles) DT Haemophilus influenzae type b (Hib) Adenovirus Anthrax Cholera DTaP United States Vaccine Names United States Vaccine United States Vaccines

Appendix B-3 Appendix B

Comments conjugate) 197 Recombinant, Adj. Recombinant, recommends ACIP 9-26 years Inactivated Adj. Inactivated, Adj. Inactivated, Inactivated Egg-Free Recombinant, Egg-free Cell-culture, Inactivated Attenuated Live Inactivated Inactivated Adj. Inactivated, Attenuated Live Inactivated (Polysaccharide toxoid diphtheria conjugate) Inactivated (Polysaccharide conjugate) toxoid tetanus Inactivated (Polysaccharide CRM Adj. Recombinant, Adj. Recombinant, Approved Ages Approved 9-45 years ≥6 months ≥65 years ≥65 years ≥6 months ≥18 years ≥4 years ≥6 months 2-49 years ≥6 months ≥65 years ≥2 months ≥12 months years 9 months-55 ≥2 years years 2 months-55 10-25 years 10-25 years Series Doses in Routine 2 or 3 1 or 2 1 1 1 or 2 1 1 or 2 1 or 2 1 or 2 1 or 2 1 2 2 2 2 2 2 or 3 2 Route IM IM IM IM IM IM IM IM Intranasal IM IM IM SC IM IM IM IM IM Manufacturer Merck Seqirus Seqirus Seqirus GlaxoSmithKline Sanofi Seqirus GlaxoSmithKline AstraZeneca Sanofi Sanofi Valneva Merck Sanofi Sanofi GlaxoSmithKline Pfizer GlaxoSmithKline Abbreviation 9vHPV IIV4 IIV3 IIV4 IIV4 RIV4 ccIIV4 IIV4 LAIV4 IIV4 HD-IIV4 JE MMR MenACWY-D MenACWY-TT MenACWY-CRM MenB-FHbp MenB-4C Trade Name Trade Gardasil® 9 Gardasil® Afluria Quadrivalent® Fluad® Fluad® Quadrivalent Fluarix™ Quadrivalent Flublok® Quadrivalent Flucelvax® Quadrivalent FluLaval™ Quadrivalent FluMist® Quadrivalent Fluzone® Quadrivalent Fluzone® High-Dose Quadrivalent Ixiaro® M-M-R® II Menactra® Menquadfi™ Menveo™ Trumenba® Bexsero™

B Vaccine Human Papillomavirus (HPV) Influenza* Japanese encephalitis Mumps, Measles, Rubella Meningococcal W, A, C, (serogroups and Y) Meningococcal B) (serogroup

Appendix B-4 Appendix B

197 Comments Live Attenuated Live Inactivated, Adj. (CRM Adj. Inactivated, Live, Monovalent Live, Adj. Inactivated, Adj. Inactivated, Inactivated Polysaccharide Inactivated Polysaccharide Inactivated Pentavalent Live, Adj. Inactivated, Adj. Inactivated, Attenuated Live Attenuated Live Non-replicating Live, Attenuated Live conjugate) Inactivated Inactivated

Approved Ages Approved ≥6 years Pediatric: ≥6 weeks Pediatric: >65 years Adult: 6-24 weeks ≥7 years 10-64 years ≥2 years ≥2 years All ages 6-32 weeks ≥7 years ≥10 years ≥12 months All ages ≥18 years ≥9 months ≥6 weeks All ages

Series (post-exposure) Doses in Routine 4 2 4 (pediatric) 4 (pediatric) 1 (adult) 2 1 (Every 10 years) 1 1 2-3 (pre-exposure) 4 1 3 1 (Every 10 years) 1 1 2 1 4 2-3 (pre-exposure) 4 (post-exposure) Route Oral (Capsules) SC IM Oral (Liquid) Oral IM IM IM IM IM or SC Oral (Liquid) Oral IM IM Percutaneous SC SC IM or SC IM Manufacturer Emergent Emergent BioSolutions Merck Pfizer GlaxoSmithKline Sanofi Sanofi Sanofi Bavarian Nordic Bavarian Merck Massachusetts Labs Biological Merck GlaxoSmithKline Emergent BioSolutions Nordic Bavarian Sanofi Sanofi Sanofi Abbreviation N/A VAR PCV13 RV1 Tdap Td N/A N/A PPSV23 Td RV5 Tdap — — YF IPV N/A TM Trade Name Trade TdVax Vivotif® Varivax® Prevnar 13® Prevnar Rotarix™ Adacel® Tenivac® Vi® Typhim RabAvert® Pneumovax® 23 Pneumovax® RotaTeq® Boostrix™ ACAM2000® JYNNEOS® YF-Vax® Ipol® Imovax®

B Vaccine Varicella Tetanus, Tetanus, (reduced) Diphtheria Typhoid Pneumococcal Rotavirus (reduced) Tetanus, Diphtheria, Pertussis (reduced) (Vaccinia) Smallpox and Smallpox Monkeypox Fever Yellow Polio Rabies of the Morbidity and Mortality Weekly Report (MMWR), the editor of and Prevention of Vaccine-Preventable Diseases (the Pink Book), ACIP members, and liaison organizations to the ACIP. the ACIP. to and liaison organizations members, Book), ACIP Diseases (the Pink Vaccine-Preventable of Reportof the Morbidity of Epidemiology and Prevention and MortalityWeekly (MMWR), the editor of Book, published in the MMWR, Pink and the American Academy Notes and Policy Recommendations used in ACIP references vaccine to approach a uniform provide to intended are abbreviations These are products in which the active components (-) indicates a hyphen vaccines, In descriptions of combination and adults. adolescents, children, schedules for Red Book, and in the U.S. Pediatrics by the user. must be mixed components products in which activeby the manufacturer; form a slash ( / ) indicates (combined) supplied in their final and not product, that number of doses for the routine represents this column vaccines, some combination doses not part or booster For schedules, of an initial series. catch-up schedules, alternative factors, and IPV series.) only 1 dose of multi-dose be used for DTaP may Kinrix or Quadracel example, (For the components. series for number of doses in a complete the total necessarily https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html May be limited in supply as manufacturer has temporarily stopped production stopped in supply as manufacturer has temporarily be limited May The abbreviations on this table (Column 3) were standardized jointly by staff of the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP) Work Groups, the editor the editor Work Groups, (ACIP) Practices Advisory on Committee Immunization Prevention, and Control for Disease Centers staff of the by jointly standardized 3) were on this table (Column abbreviations The conditions or other high-risk with health patients reflect for schedules It does not necessarily ages. recommended at the patient to a healthy 6) reflects doses administered (Column “Doses in a Routine Series” an adjuvant. contains the vaccine that indicates column “Comments” in the “Adj.” the 7th birthday]). [to 6 years through means 6 weeks years” “6 weeks-6 (i.e., “through” means in an age range A hyphen on influenza, see: recommendations For the most current 2020-2021 northernformulations. in this table are vaccines *All influenza hemisphere †

Appendix B-5 Appendix B Comments Inactivated, Adj.: Approved as Approved Adj.: Inactivated, and 4th IPV. 5th DTaP as Approved Adj.: Inactivated, and 4th IPV. 5th DTaP for Approved Adj.: Inactivated, doses. 2, 4, 6 month Approved Adj.: 4 Inactivated, doses. 2, 4, 6, 15-18 month for for Approved Adj.: Inactivated, doses. 2, 4, 6 month Adj. Inactivated/Recombinant, HepB HepA + Adult Pediatric Attenuated Live

Ages Approved Approved 4-6 years 4-6 years years 6 weeks-6 years 6 weeks-4 years 6 weeks-4 ≥18 years 12 months- 12 years

Series Routine Doses in 1 1 3 4 3 3 2 Route IM IM IM IM IM IM SC Manufacturer GlaxoSmithKline Sanofi GlaxoSmithKline Sanofi Sanofi GlaxoSmithKline Merck Abbreviation DTaP-IPV DTaP-IPV DTaP-HepB-IPV DTaP-IPV/Hib DTaP-IPV-Hib-HepB HepA-HepB MMRV Trade Trade Name Kinrix™ Quadracel® Pediarix™ Pentacel® Vaxelis™ Twinrix™ ProQuad®

B Vaccine DTaP, Polio DTaP, B, hepatitis DTaP, Polio Polio, DTaP, Haemophilus influenzae type b Polio, DTaP, Haemophilus influenzae type b, B hepatitis A, Hepatitis B Hepatitis Mumps, Measles, Rubella, Varicella of the Morbidity and Mortality Weekly Report (MMWR), the editor of Epidemiology and Prevention of Vaccine-Preventable Diseases (the Pink Book), ACIP members, and liaison organizations to the ACIP. the ACIP. to and liaison organizations members, Book), ACIP Diseases (the Pink Vaccine-Preventable of Reportof the Morbidity of Epidemiology and Prevention and MortalityWeekly (MMWR), the editor of Book, published in the MMWR, Pink and the American Academy Notes and Policy Recommendations used in ACIP references vaccine to approach a uniform provide to intended are abbreviations These are products in which the active components (-) indicates a hyphen vaccines, In descriptions of combination and adults. adolescents, children, schedules for immunization Red Book, and in the U.S. Pediatrics by the user. must be mixed components products in which activeby the manufacturer; form a slash ( / ) indicates (combined) supplied in their final and not product, that number of doses for the routine represents this column vaccines, some combination doses not part or booster For schedules, of an initial series. catch-up schedules, alternative factors, and IPV series.) only 1 dose of multi-dose be used for DTaP may Kinrix or Quadracel example, (For the components. series for number of doses in a complete the total necessarily The abbreviations on this table (Column 3) were standardized jointly by staff of the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP) Work Groups, the editor the editor Work Groups, (ACIP) Practices Advisory on Committee Immunization Prevention, and Control for Disease Centers staff of the by jointly standardized 3) were on this table (Column abbreviations The conditions or other high-risk with health patients reflect for schedules It does not necessarily ages. recommended at the patient to a healthy 6) reflects doses administered (Column “Doses in a Routine Series” an adjuvant. contains the vaccine that indicates column “Comments” in the “Adj.” the 7th birthday]). [to 6 years through means 6 weeks years” “6 weeks-6 (i.e., “through” means in an age range A hyphen 2021 February United States Combination Vaccines

Appendix B-6 Appendix B Vaccine Excipient Summary Excipients Included in U.S. Vaccines, by Vaccine In addition to weakened or killed disease antigens (such as weakened, killed, or parts of or bacteria), vaccines contain very small amounts of other ingredients – excipients . Some excipients are added to a vaccine for a specific purpose . These include: y Preservatives, to prevent contamination . For example, thimerosal . y Adjuvants, to help stimulate a stronger immune response . For example, aluminum salts . y Stabilizers, to keep the vaccine potent during transportation and storage . For example, sugars or gelatin .

Others are residual trace amounts of materials that were used during the manufacturing process and removed . These can include: y Cell culture materials, used to grow the vaccine antigens . For example, egg protein, various culture media . y Inactivating ingredients, used to kill viruses or inactivate toxins . For example, formaldehyde . y Antibiotics, used to prevent contamination by bacteria . For example, neomycin .

The following table lists substances, other than active ingredients (i e. ,. antigens), shown in the manufacturers’ package insert (PI) as being contained in the final formulation of each vaccine . Substances used in the manufacture of a vaccine but not listed as contained in the final product (e.g., culture media) can be found in each PI, but are not shown on this table. Each PI, which can be found on the FDA’s website (see below) contains a description of that vaccine’s manufacturing process, including the amount and purpose of each substance . In most PIs, this information is found in Section 11: “Description ”. Please refer to the PI for a complete list of ingredients or excipients . A table listing vaccine excipients and media by excipient is published by the Institute for Vaccine Safety at Johns Hopkins University, and can be found at http://www vaccinesafety. edu/. components-Excipients htm. .

B

Appendix B-7 Appendix B Vaccine Excipient Table

Vaccine (Trade Name) Package (a) Insert Date Contains Adenovirus 10/2019 monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum albumin, potassium phosphate, plasdone C, anhydrous lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate, cellulose acetate phthalate, alcohol, acetone, castor oil, FD&C Yellow #6 aluminum lake dye Anthrax (Biothrax) 11/2015 aluminum hydroxide, , benzethonium chloride, formaldehyde BCG (Tice) 02/2009 glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron ammonium citrate, lactose Cholera (Vaxchora) 06/2016 ascorbic acid, hydrolyzed casein, sodium chloride, sucrose, dried lactose, sodium bicarbonate, sodium carbonate Dengue (Dengvaxia) 06/2019 sodium chloride, essential amino acids (including L-phenylalanine), non-essential amino acids, L-arginine hydrochloride, sucrose, D-trehalose dihydrate, D-sorbitol, trometamol, urea DT (Sanofi) 06/2018 aluminum phosphate, isotonic sodium chloride, formaldehyde DTaP (Daptacel) 01/2021(b) aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol DTaP (Infanrix) 01/2021(b) formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80) DTaP-IPV (Kinrix) 01/2021(b) formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B DTaP-IPV (Quadracel) 02/2021 formaldehyde, aluminum phosphate, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate, bovine serum albumin DTaP-HepB-IPV (Pediarix) 01/2021(b) formaldehyde, aluminum hydroxide, aluminum phosphate, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, protein DTaP-IPV/Hib (Pentacel) 12/2019 aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate DTaP-IPV-Hib-HepB (Vaxelis) 10/2020 polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, ammonium thiocyanate, yeast protein, aluminum Ebola Zaire (ERVEBO) 01/2021(b) Tromethamine, rice-derived recombinant human serum albumin, host cell DNA, benzonase, rice protein Hib (ActHIB) 05/2019 sodium chloride, formaldehyde, sucrose Hib (Hiberix) 04/2018 formaldehyde, sodium chloride, lactose Hib (PedvaxHIB) 01/2021(b) amorphous aluminum hydroxyphosphate sulfate, sodium chloride Hep A (Havrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum hydroxide, amino acid supplement, phosphate-buffered saline solution, polysorbate 20, neomycin sulfate, aminoglycoside antibiotic Hep A (Vaqta) 01/2021(b) amorphous aluminum hydroxyphosphate sulfate, non-viral protein, DNA, bovine albumin, formaldehyde, neomycin, sodium borate, sodium chloride, other process chemical residuals Hep B (Engerix-B) 01/2021(b) aluminum hydroxide, yeast protein, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate Hep B (Recombivax) 12/2018 formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, yeast protein B Hep B (Heplisav-B) 05/2020 yeast protein, yeast DNA, deoxycholate, phosphorothioate linked oligodeoxynucleotide, sodium phosphate, dibasic dodecahydrate, sodium chloride, monobasic dehydrate, polysorbate 80 Hep A/Hep B (Twinrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum phosphate, aluminum hydroxide, amino acids, sodium chloride, phosphate buffer, polysorbate 20, neomycin sulfate, yeast protein HPV (Gardasil 9) 08/2020 amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-, polysorbate 80, sodium borate, yeast protein

Appendix B-8 Appendix B

Vaccine Excipient Table Package (a) Vaccine (Trade Name) Insert Date Contains Vaccine (Trade Name) Package Contains(a) Insert Date Influenza (Afluria) 07/2020 sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, Quadrivalent(c) monobasic potassium phosphate, potassium chloride, calcium chloride, sodium Adenovirus 10/2019 monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum taurodeoxycholate, ovalbumin, sucrose, neomycin sulfate, polymyxin B, beta- albumin, potassium phosphate, plasdone C, anhydrous lactose, microcrystalline propiolactone, hydrocortisone, thimerosal (multi-dose vials) cellulose, polacrilin potassium, magnesium stearate, cellulose acetate phthalate, alcohol, acetone, castor oil, FD&C Yellow #6 aluminum lake dye Influenza (Fluad)(c) 10/2020 squalene, polysorbate 80, sorbitan trioleate, sodium citrate dehydrate, citric acid monohydrate, neomycin, kanamycin, hydrocortisone, egg proteins, Anthrax (Biothrax) 11/2015 aluminum hydroxide, sodium chloride, benzethonium chloride, formaldehyde cetyltrimethylammonium bromide (CTAB), formaldehyde BCG (Tice) 02/2009 glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron Influenza (Fluad) 11/2020 squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid ammonium citrate, lactose Quadrivalent(c) monohydrate, neomycin, kanamycin, hydrocortisone, egg protein, formaldehyde Cholera (Vaxchora) 06/2016 ascorbic acid, hydrolyzed casein, sodium chloride, sucrose, dried lactose, sodium Influenza (Fluarix) 07/2020 octoxynol-10 (TRITON X-100), α-tocopheryl hydrogen succinate, polysorbate bicarbonate, sodium carbonate Quadrivalent(c) 80 (Tween 80), hydrocortisone, gentamicin sulfate, ovalbumin, formaldehyde, Dengue (Dengvaxia) 06/2019 sodium chloride, essential amino acids (including L-phenylalanine), non-essential sodium deoxycholate, sodium phosphate-buffered isotonic sodium chloride amino acids, L-arginine hydrochloride, sucrose, D-trehalose dihydrate, D-sorbitol, Influenza (Flublok) 06/2020 sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, trometamol, urea Quadrivalent(c) polysorbate 20 (Tween 20), baculovirus and Spodoptera frugiperda cell proteins, DT (Sanofi) 06/2018 aluminum phosphate, isotonic sodium chloride, formaldehyde baculovirus and cellular DNA, Triton X-100 DTaP (Daptacel) 01/2021(b) aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol Influenza (Flucelvax) 03/2020 Madin Darby Canine Kidney (MDCK) cell protein, phosphate buffered saline, Quadrivalent(c) protein other than HA, MDCK cell DNA, polysorbate 80, cetyltrimethlyammonium (b) DTaP (Infanrix) 01/2021 formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80) bromide, and β-propiolactone, thimerosal (multi-dose vials) (b) DTaP-IPV (Kinrix) 01/2021 formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween Influenza (Flulaval) 2020 ovalbumin, formaldehyde, sodium deoxycholate, α-tocopheryl hydrogen 80), neomycin sulfate, polymyxin B Quadrivalent(c) succinate, polysorbate 80, phosphate-buffered saline solution DTaP-IPV (Quadracel) 02/2021 formaldehyde, aluminum phosphate, 2-phenoxyethanol, polysorbate 80, Influenza (Fluzone) 2020 formaldehyde, egg protein, octylphenol ethoxylate (Triton X-100), sodium glutaraldehyde, neomycin, polymyxin B sulfate, bovine serum albumin Quadrivalent(c) phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose DTaP-HepB-IPV (Pediarix) 01/2021(b) formaldehyde, aluminum hydroxide, aluminum phosphate, sodium chloride, vials) polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein Influenza (Fluzone) 2020 egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered DTaP-IPV/Hib (Pentacel) 12/2019 aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, High Dose(c) isotonic sodium chloride solution, formaldehyde bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate Influenza (FluMist) 08/2020 monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic DTaP-IPV-Hib-HepB (Vaxelis) 10/2020 polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, Quadrivalent(c) potassium phosphate, monobasic potassium phosphate, ovalbumin, gentamicin neomycin, streptomycin sulfate, polymyxin B sulfate, ammonium thiocyanate, sulfate, ethylenediaminetetraacetic acid (EDTA) yeast protein, aluminum IPV (Ipol) 01/2021(b) calf bovine serum albumin, 2-phenoxyethanol, formaldehyde, neomycin, Ebola Zaire (ERVEBO) 01/2021(b) Tromethamine, rice-derived recombinant human serum albumin, host cell DNA, streptomycin, polymyxin B, M-199 medium benzonase, rice protein Japanese Encephalitis (Ixiaro) 09/2018 aluminum hydroxide, protamine sulfate, formaldehyde, bovine serum albumin, Hib (ActHIB) 05/2019 sodium chloride, formaldehyde, sucrose host cell DNA, sodium metabisulphite, host cell protein Hib (Hiberix) 04/2018 formaldehyde, sodium chloride, lactose MenACWY (Menactra) 04/2018 sodium phosphate buffered isotonic sodium chloride solution, formaldehyde, diphtheria toxoid protein carrier Hib (PedvaxHIB) 01/2021(b) amorphous aluminum hydroxyphosphate sulfate, sodium chloride MenACWY (MenQuadfi) 01/2021(b) sodium chloride, sodium acetate, formaldehyde Hep A (Havrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum hydroxide, amino acid supplement, phosphate-buffered saline solution, polysorbate 20, neomycin sulfate, MenACWY (Menveo) 07/2020 formaldehyde, CRM197 protein aminoglycoside antibiotic MenB (Bexsero) 01/2021(b) aluminum hydroxide, sodium chloride, histidine, sucrose, kanamycin (b) Hep A (Vaqta) 01/2021 amorphous aluminum hydroxyphosphate sulfate, non-viral protein, DNA, bovine MenB (Trumenba) 2018 polysorbate 80, aluminum phosphate, histidine buffered saline albumin, formaldehyde, neomycin, sodium borate, sodium chloride, other process chemical residuals MMR (MMR-II) 12/2020 sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, neomycin, fetal bovine serum, WI-38 human diploid lung fibroblasts Hep B (Engerix-B) 01/2021(b) aluminum hydroxide, yeast protein, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate MMRV (ProQuad) 01/2021(b) MRC-5 cells including DNA and protein, sucrose, hydrolyzed gelatin, sodium (Frozen: Recombinant chloride, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, Hep B (Recombivax) 12/2018 formaldehyde, potassium aluminum sulfate, amorphous aluminum Albumin) recombinant human albumin, sodium bicarbonate, potassium phosphate hydroxyphosphate sulfate, yeast protein monobasic, potassium chloride, potassium phosphate dibasic, neomycin, bovine Hep B (Heplisav-B) 05/2020 yeast protein, yeast DNA, deoxycholate, phosphorothioate linked calf serum, other buffer and media ingredients B oligodeoxynucleotide, sodium phosphate, dibasic dodecahydrate, sodium PCV13 (Prevnar 13) 08/2017 CRM carrier protein, polysorbate 80, succinate buffer, aluminum phosphate chloride, monobasic dehydrate, polysorbate 80 197 PPSV-23 (Pneumovax) 09/2020 isotonic saline solution, phenol Hep A/Hep B (Twinrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum phosphate, aluminum hydroxide, amino acids, sodium chloride, phosphate buffer, polysorbate 20, neomycin Rabies (Imovax) 10/2019 human albumin, neomycin sulfate, phenol red, beta-propiolactone sulfate, yeast protein Rabies (RabAvert) 2018 chicken protein, polygeline (processed bovine gelatin), human serum albumin, HPV (Gardasil 9) 08/2020 amorphous aluminum hydroxyphosphate sulfate, sodium chloride, potassium glutamate, sodium EDTA, ovalbumin, neomycin, chlortetracycline, L-histidine, polysorbate 80, sodium borate, yeast protein amphotericin B Rotavirus (RotaTeq) 01/2021(b) sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, fetal bovine serum

Appendix B-9 Appendix B

Vaccine (Trade Name) Package (a) Insert Date Contains Rotavirus (Rotarix) 01/2021(b) dextran, Dulbecco’s Modified Eagle Medium (sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red), sorbitol, sucrose, calcium carbonate, sterile water, xanthan [Porcine circovirus type 1 (PCV1) is present in Rotarix. PCV-1 is not known to cause disease in humans.] Smallpox 03/2018 HEPES, 2% human serum albumin, 0.5 - 0.7% sodium chloride USP, 5% Mannitol (Vaccinia) (ACAM2000) USP, neomycin, polymyxin B, 50% Glycerin USP, 0.25% phenol USP Td (Tenivac) 11/2019 aluminum phosphate, formaldehyde, sodium chloride Td (TDVAX) 09/2018 aluminum phosphate, formaldehyde, thimerosal Tdap (Adacel) 12/2020 aluminum phosphate, formaldehyde, 2-phenoxyethanol, glutaraldehyde Tdap (Boostrix) 09/2020 formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 Typhoid (Typhim Vi) 03/2020 formaldehyde, phenol, polydimethylsiloxane, disodium phosphate, , sodium chloride Typhoid (Vivotif ) 9/2013 sucrose, ascorbic acid, amino acids, lactose, magnesium stearate, gelatin Varicella (Varivax) Frozen 01/2021(b) sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 human diploid cells including DNA & protein, sodium phosphate monobasic, EDTA, neomycin, fetal bovine serum Yellow Fever (YF-Vax) 2/2019 sorbitol, gelatin, sodium chloride Zoster (Shingles) (Shingrix) 01/2021(b) sucrose, sodium chloride, dioleoyl phosphatidylcholine (DOPC), 3-O-desacl- 4’monophosphoryl lipid A (MPL), QS-21 (a saponin purified from plant extract Quillaja saponaria Molina), potassium dihydrogen phosphate, cholesterol, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, dipotassium phosphate, polysorbate 80, host cell protein and DNA

Abbreviations: DT = diphtheria and tetanus ; DTaP = diphtheria and tetanus toxoids and acellular pertussis; Hep A = Hepatitis A; Hep B = Hepatitis B; Hib = Haemophilus influenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated ; MenACWY = quadrivalent meningococcal ; MenB = serogroup B ; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, varicella; PCV13 = pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

(a)All information was extracted from manufacturers’ package inserts. The date shown in the Date column of the table is the edition date of the PI in use in January 2021 by month and year. In some cases, only a year was printed on the PI. If in doubt about whether a PI has been updated since this table was prepared, check the FDA’s website at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm (b)The PI was not dated and this is the date the PI was reviewed for this table. (c)All influenza vaccine in this table are 2020-21 northern hemisphere formulation. January 2021

B

Appendix B-10 Appendix B

Latex in Vaccine Packaging “Immediate-type allergic reactions due to latex allergy have been described after , but such reactions are rare . If a person reports a severe anaphylactic allergy to latex, vaccines supplied in vials or syringes that contain natural rubber latex should be avoided if possible . If not, if the decision is made to vaccinate, providers should be prepared to treat immediate allergic reactions due to latex, including anaphylaxis . The most common type of latex hypersensitivity is a delayed-type (type 4, cell-mediated) allergic contact dermatitis . For patients with a history of contact allergy to latex, vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex may be administered ”. (ACIP General Best Practice Guidelines for Immunization)

Vaccine (Trade Name) Package Insert Date Latex (Yes/No)(a) Adenovirus 10/2019 No Anthrax (Biothrax) 11/2015 Yes BCG (Tice) 02/2009 No Cholera (Vaxchora) 06/2016 No Dengue (Dengvaxia) 06/2019 No DT (Sanofi) 06/2018 No DTaP (Daptacel) 01/2021(b) No DTaP (Infanrix) 01/2021(b) Yes – Syringe, No – Vial DTaP-IPV (Kinrix) 01/2021(b) Yes – Syringe, No – Vial DTaP-IPV (Quadracel) 02/2021 No DTaP-HepB-IPV (Pediarix) 01/2021(b) Yes DTaP-IPV/Hib (Pentacel) 12/2019 No DTaP-IPV-Hib-HepB (Vaxelis) 10/2020 No Ebola Zaire (ERVEBO) 01/2021(b) No Hib (ActHIB) 05/2019 No Hib (Hiberix) 04/2018 No Hib (PedvaxHIB) 01/2021(b) Yes Hep A (Havrix) 01/2021(b) Yes – Syringe , No – Vial Hep A (Vaqta) 01/2021(b) Yes – Syringe, Yes – Vial Hep B (Engerix-B) 01/2021(b) Yes – Syringe, No – Vial Hep B (Recombivax) 12/2018 Yes – Syringe, Yes – Vial Hep B (Heplisav-B) 05/2020 No Hep A/Hep B (Twinrix) 01/2021(b) Yes HPV (Gardasil 9) 08/2020 No Influenza (Afluria) Quadrivalent(c) 07/2020 No Influenza (Fluad) (c) 10/2020 No Influenza (Fluad) Quadrivalent(c) 11/2020 No Influenza (Fluarix) Quadrivalent(c) 07/2020 No B Influenza (Flublok) Quadrivalent(c) 06/2020 No Influenza (Flucelvax) Quadrivalent(c) 03/2020 No Influenza (Flulaval) Quadrivalent(c) 2020 No Influenza (Fluzone) Quadrivalent(c) 2020 No Influenza (Fluzone) High Dose(c) 2020 No Influenza (FluMist) Quadrivalent(c) 08/2020 No

Appendix B-11 Appendix B

Vaccine (Trade Name) Package Insert Date Latex (Yes/No)(a) IPV (Ipol) 01/2021(b) No Japanese Encephalitis (Ixiaro) 09/2018 No MenACWY (Menactra) 04/2018 No MenACWY(MenQuadfi) 01/2021(b) No MenACWY (Menveo) 07/2020 No MenB (Bexsero) 01/2021(b) Yes MenB (Trumenba) 2018 No MMR (M-M-R II) 12/2020 No MMRV (ProQuad) (Frozen: Recombinant Albumin) 01/2021(b) No PCV13 (Prevnar 13) 08/2017 No PPSV-23 (Pneumovax) 09/2020 No Rabies (Imovax) 10/2019 No Rabies (RabAvert) 2018 No Rotavirus (RotaTeq) 01/2021(b) No Rotavirus (Rotarix) 01/2021(b) Yes Smallpox (Vaccinia) (ACAM2000) 03/2018 No Td (Tenivac) 11/2019 Yes – Syringe, No – Vial Td (TDVAX) 09/2018 No Tdap (Adacel) 12/2020 Yes(d) – Syringe, No – Vial Tdap (Boostrix) 09/2020 Yes – Syringe, No – Vial Typhoid (Typhim Vi) 03/2020 No Typhoid (Vivotif Ty21a) 09/2013 No Varicella (Varivax) Frozen 01/2021(b) No Yellow Fever (YF-Vax) 02/2019 No Zoster (Shingles) (Shingrix) 01/2021(b) No

Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; Hep A = Hepatitis A; Hep B = Hepatitis B; Hib = Haemophilus influenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MenB = serogroup B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, varicella; PCV13 = pneumococcal conjugate vaccine; PI = Package Insert; PPSV23= pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

(a)All information was extracted from manufacturers’ package inserts. The date shown in the Date column of the table is the edition date of the PI is use in February 2020. If in doubt about whether a PI has been updated since this table was prepared, check the FDA’s website at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm (b)The PI was not dated and this is the date the PI was reviewed for this table. (c) All influenza vaccine in this table are 2020-21 northern hemisphere formulation. (d)The most current PI (12/2020) indicates no latex in any presentation of Adacal. Previous PIs indicate tip caps of some lots of Adacel prefilled syringes contain latex while others do not. Check the package insert that came with your vaccine, if necessary. January 2021 B

Appendix B-12 Appendix B

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Appendix B-13 Appendix B

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Appendix B-14 Appendix B Resources for Vaccines Vaccine Excipients y Food and Drug Administration (FDA) Vaccine Package Inserts: https://www .fda .gov/vaccines-blood-biologics/ vaccines/vaccines-licensed-use-united-states

y Thimerosal and Vaccines (FDA): https://www .fda .gov/vaccines-blood-biologics/safety-availability-biologics/ thimerosal-and-vaccines

y Thimerosal and Vaccines (CDC): https://www .cdc .gov/vaccinesafety/concerns/thimerosal/index .html

y Common Ingredients in U S. . Licensed Vaccines (FDA): https://www .fda .gov/vaccines-blood-biologics/safety- availability-biologics/common-ingredients-us-licensed-vaccines

y Excipients in Vaccines per 0 5. mL dose (Johns Hopkins): https://www vaccinesafety. edu/components-Excipients. htm.

Interpreting Vaccines from Other Countries y World Health Organization (WHO) Country Profiles: https://apps who. int/immunization_monitoring/globalsummary.

B

Appendix B-15 Appendix B

B

Appendix B-16